JP4238134B2 - Liposuction device and method and enclosed suction system and method - Google Patents

Abstract

Liposuction devices and methods and surrounding aspiration systems and methods that reduce the chances of burning and necrosis. The devices include an evacuation tube surrounding an ultrasonic probe, including the distal end thereof to define a liquefaction and/or rupture chamber. The evacuation tube has one or more openings in the distal end through which tissue such as fatty tissue may enter for rupture/liquefaction therein. Containing the ultrasonic probe within the evacuation tube avoids any possible contact with surrounding tissue other than tissue that gets drawn into the liquefaction and/or rupture chamber. The size of the liquefaction and/or rupture chamber may be variable by adjustment of the axial position of the evacuation tube relative to the ultrasonic probe, or by selection of evacuation tubes of the desired length. Various embodiments are disclosed.

Description

Related applications

(Mutual citation of related applications)
This application claims the benefit of US Provisional Patent Application No. 60 / 337,045, filed Nov. 8, 2001.

  The present invention relates to the field of ultrasound assisted liposuction.

  Various instruments and methods of ultrasound assisted liposuction are known in the art. Such devices are described in U.S. Pat. Nos. 4,886,491, 5,123,903, 5,419,761, 5,514,086, 6,033,375, , 270,471, 6,336,925, 6,368,299, 6,379,326, 6,428,499, and US Patent Application Publication No. 2001/0012922, Including those described in 2002/0029054 and 2002/0107446.

  In ultrasound-assisted aspiration, the objective is to use ultrasonic energy to liquefy body fat and remove it through a cannula that is almost immediately after. In some instruments, the probe itself to which ultrasonic energy is applied forms the cannula, while in other instruments it forms an annular passage between the probe and the sheath for extraction purposes, and between the proximal end of the probe and the middle. Another sheath is provided on the probe to isolate the part from the surrounding tissue. This is important. Otherwise, the body entry point and adjacent tissue may be constantly or at least repeatedly subjected to ultrasonic energy and easily inflamed. This can occur even if the distal end of the probe continues to move to prevent such problems. In instruments where the ultrasonic probe itself forms a cannula, resonance techniques are used to reduce probe ultrasonic vibrations other than its distal end.

  In any case, the purpose of such a device is to efficiently remove adipose tissue from the body while preventing damage to surrounding tissues, blood vessels, etc. as much as possible. The present invention has similar safety and efficiency objectives and many other objectives as will become apparent from the disclosure herein. Without being limited thereto, it incorporates features that enable the safety and efficiency of the instrument of the present invention to be achieved by the instrument itself, regardless of operator skill or experience.

  It is an object of the present invention to provide a liposuction device and method, as well as an enclosed suction system and method that reduce the possibility of inflammation and necrosis.

  The instrument includes an evacuation tube that surrounds the ultrasound probe, which includes a distal end that defines a liquefaction and / or destruction chamber. The evacuation tube has one or more openings at the distal end through which tissue such as adipose tissue can enter for destruction / liquefaction. An ultrasonic probe is included in the evacuation tube to prevent any possibility of contact with surrounding tissue other than tissue drawn into the liquefaction and / or destruction chamber. The size of the liquefaction and / or destruction chamber can be changed by adjusting the axial position of the evacuation tube relative to the ultrasound probe or by selecting the desired length of evacuation tube.

  In the following description, a preferred embodiment of the invention and certain variations thereof are described in detail. However, it is to be understood that the description of specific modifications is for illustrative purposes only and is not intended to exclude other modifications in the same or other parts of the preferred embodiment disclosed.

  Referring first to FIG. 1, an embodiment of a surgical ultrasonic liposuction device according to the present invention is shown in side view. In the apparatus of FIG. 1, a vacuum exhaust pipe 20, a front handpiece 22 and a rear handpiece 24 can be seen. Also seen in FIG. 1 is a suction conduit 26, which is configured to be removably attached to a suction unit that performs suction so as to remove material from the evacuation tube 20. Finally, the adjustment ring 28 can be seen in FIG. This holds the evacuation tube 20 on the front handpiece 22 at the desired axial position.

  Referring now to FIGS. 2 and 3, there are shown a developed view and a cross-sectional view of the embodiment of the ultrasound assisted liposuction device of FIG. 1, respectively. In the preferred embodiment, a solid probe 30 is used, but other structures, such as hollow probes, can be used if desired. The probe 30 is coupled to an ultrasonic vibration unit 32, usually a piezoelectric drive unit (which may be a conventional commercial unit). In general, the design and structure of such piezoelectric drive units and probes themselves are well known in the prior art, and therefore details of the design of the probe 30 and the ultrasonic vibration unit 32 need not be provided herein.

  The ultrasonic probe assembly of FIG. 2 is attached to the outer assembly. The main parts of the outer assembly include the evacuation tube 20, the front handpiece 22, the rear handpiece 24, the suction conduit 26, and the adjustment ring 28, all also shown in FIG. The O-ring 34 is attached between the front handpiece 22 and the rear handpiece 24 and functions in the groove 33 of the main body of the ultrasonic vibration unit 32.

  Next, with particular reference to FIG. 3, the ultrasonic vibration unit 32 is captured by them in the region between the front and rear handpieces, while against the ultrasonic vibration unit 32 within the O-ring groove (FIG. 2). The O-ring 34 that is captured is slip-fitted inside the front handpiece 22 and the rear handpiece 24 so as to be axially disposed with respect to them. The O-ring is also provided with a seal, but not necessarily a hermetic seal, to define a chamber 36 in fluid communication with the vent 38, the suction conduit 26, and the opening 40 at the distal end of the evacuation tube 20. ing. That is, the opening 40 at the end of the vacuum exhaust pipe communicates with the suction conduit 26 through an annular gap between the outer diameter of the ultrasonic probe 30 and the inner diameter of the vacuum exhaust pipe 20. A vent 38 is in fluid communication with the suction conduit 26. In use, when the surgeon covers the vent 38 with his hand, adipose tissue is aspirated into the liquefaction and / or destruction chamber 42 between the end of the probe and the evacuation tube by the suction force of the suction conduit 26, The liquefaction of fat is promoted inside, and the fat is sucked out through the space between the probe and the vacuum exhaust pipe, and finally through the suction conduit. If the vent 38 is not covered or occluded, air will flow through the vent between the ultrasonic vibration unit and the front handpiece to the suction conduit and thereby through the vacuum exhaust pipe. No suction is performed.

  4a to 4d, an exemplary variation of the size of the opening 40 at the end of the evacuation tube 20 is shown. The evacuation tube is not a permanent part of the assembly and can be easily removed and replaced with another evacuation tube so that the surgeon can perform the surgeon's work and techniques either before or during the surgery. You can select the size of the aperture that you think is best suited to your needs. The shape of the opening need not be circular, but may be other shapes, such as a rectangle as shown in FIG. 4e, and can be oriented on the assembly as desired by the surgeon. Also, a plurality of openings can be used at the tip, such as the two openings 40 in FIG. 4f or the four openings in FIG. 4g. Further, instead of or in addition to one or more openings 40 at the distal end of the evacuation tube, an opening is provided along the length of the evacuation tube and / or along at least a portion thereof. You can also. As an example, FIG. 4h shows one opening 40 in the center of the distal end of the evacuation tube and four openings 40 on the side of the distal end that are further in the region of the liquefaction and / or destruction chamber. Yes. One or more openings can also be provided, or further along the length of the evacuation tube. In general, it is preferred that the edge of the opening or openings be sufficiently rounded in cross-section, and usually, but not necessarily, the hole or opening at the end of the evacuation tube has a cross-sectional area of the evacuation tube. Smaller than the inner diameter of the shaft and concentrated with respect to the shaft.

  5a and 5b, it can be seen that the size (length) of the liquefaction and / or destruction chamber 42 (the chamber between the end of the probe 30 and the evacuation tube 20) can be adjusted. As shown in the figure, the evacuation pipe 20 is screwed into the front handpiece and is locked in place by a lock ring 28. The length by which the evacuation tube is screwed into the front handpiece 22 is long enough to be extended in various axial directions and locked to the front handpiece with a lock ring. As an example, FIG. 5b shows that the evacuation tube 20 is locked in the extended position, thereby creating a substantial length of liquefaction and / or destruction chamber 42. FIG. FIG. 5a shows that the evacuation tube 20 is locked in the unextended position, thereby creating a liquefaction and / or destruction chamber 42 of almost zero length. This adjustment can be made by the surgeon to meet specific needs and desires, and can be adjusted even during liposuction, as the condition indicates.

  Even though the vacuum exhaust tube is in the position shown in FIG. 5b, the ultrasound probe liquefies adipose tissue entering the liquefaction and / or destruction chamber 42, but escapes from the liquefaction and / or destruction chamber 42 and distant from the vacuum exhaust pipe. Less ultrasonic energy causes inflammation and necrosis of the tissue surrounding the distal edge. This is also advantageous for surgeons with little or no experience. This is because it can be kept in one place without causing irritation or necrosis, and low speed movements can be used when sculpturing the removed fat for best cosmetic results. For faster mass removal, a smaller (short) liquefaction and / or destruction chamber 42 may be used, possibly with a larger opening at the end of the evacuation tube 20 at the evacuation tube 20. is there. Furthermore, even in this case, the fact that the probe only contacts the tissue that has entered the evacuation tube reduces the likelihood of inflammation and necrosis compared to many prior art techniques.

  The adjustability of the present invention is accomplished by screwing the evacuation tube 20 to the front handpiece, but other adjustable attachment mechanisms can be used, or as another alternative, differing in length. Adjustments can also be made by selecting the particular evacuation tube to be used from among the various evacuation tubes.

  In use, the present invention typically uses a two-step procedure. First, the liquefaction and / or destruction chamber is wetted / infiltrated with adipose tissue, and then aspiration, liquefaction and destruction of the adipose tissue is performed simultaneously. When the process begins, it can usually continue in a nearly continuous fashion until it is complete. In this respect, the suction force used for suction may be the same as or similar to that used in other liposuction devices and can therefore be provided by prior art devices for this purpose. The suction force can also be effectively provided by other means such as a syringe, natural drainage, or a peristaltic pump, to name a few alternatives.

  One preferred embodiment has been described herein with respect to using an ultrasound probe for liposuction purposes. However, as another example, it should be understood that other forms of energy, such as high frequency energy, can be used. The devices and methods of the present invention can also be applied to the removal of agglomerated tissues such as organs, muscles or tumors, and some non-medical applications, for example.

The following summarizes and provides some preferred parameters.
The enclosed suction system of the preferred embodiment comprises:
a) a suction tube surrounding the ultrasound probe;
b) Consists of two parts, a container surrounding the ultrasonic handpiece, in a preferred embodiment a two-part container.

  In a preferred embodiment, the suction tube is disposable (single use). In an alternative embodiment, the suction tube can be reused (multiple uses) and can be sterilized by steam autoclave or other standard sterilization methods. A suction tube coaxially surrounds the ultrasound probe along the entire shaft and extends beyond the distal end of the ultrasound probe. In a preferred embodiment, the ultrasound probe is solid, but in alternative embodiments the ultrasound probe may be hollow. In a preferred embodiment, the solid ultrasonic probe is made of a titanium alloy, although the ultrasonic probe can be made of titanium, titanium alloy, stainless steel, polymer, or other material.

  The proximal end of the suction tube is removably connected to the container of the ultrasonic handpiece. The enclosure suction tube and ultrasonic handpiece container may be made of polytetrafluoroethylene (PTFE, eg Teflon, Teflon), polymer, or one or more other non-metallic or metallic materials, as desired. You can also. Materials (eg, polytetrafluoroethylene) that are preferably used to manufacture enclosed suction tubes and ultrasonic handpiece containers have a low coefficient of friction, provide thermal / motion insulation / barriers, and titanium ultrasonic It is compatible with the probe and biocompatible with the human body. Because the coefficient of friction is low, even if the suction tube is bent to the extent that it touches the ultrasonic probe, the ultrasonic energy reaching the tip of the probe will not be significantly reduced, so that the liposuction process will be bent and contacted in this way. It is not hindered by doing.

  The container of the ultrasonic handpiece includes a decompression / collection chamber, a decompression hole, and a removable suction connector that can apply a suction force. A flexible or O-ring seals the space between the inner surface of the container surrounding the ultrasonic handpiece and the outer surface of the portion of the ultrasonic handpiece that includes the piezoelectric transducer assembly, in proximity to the vacuum / collection chamber.

  A space between the outer surface of the ultrasonic probe and the inner surface of the suction tube forms a suction passage from the tip of the suction tube to the suction connector of the container of the ultrasonic handpiece. This space, i.e. the suction passage, can be varied in the range of 0.2 mm to 3 mm.

  The vacuum hole is usually plugged with the user's finger and at the same time suction is provided to the suction tube when suction is applied to the suction connector of the ultrasonic handpiece container. The diameter of the decompression hole is preferably in the range of 1 mm to 1.5 cm. The vacuum hole provides a passage between the inner surface of the liquefaction and / or destruction chamber and the outer surface of the ultrasonic handpiece container, thereby stopping the suction force through the suction path as soon as the vacuum hole is not blocked.

  An opening at the distal end of the suction tube enters the adipose tissue that is liquefied and / or broken into the space between the tip of the ultrasound probe and the tip of the suction tube. The space between the tip of the ultrasound probe and the tip of the suction tube is called the liquefaction and / or destruction chamber and operates for that purpose. This chamber is totally solid, so that the ultrasound probe and its tip are separated so that they do not come into direct contact with the structure around the subcutaneous fat (eg nerves, blood vessels, connective tissue, etc.) and the dermis. Is preventing. When ultrasonic energy is applied to the ultrasonic probe, adipose tissue entering the liquefaction and / or destruction chamber is liquefied and / or destroyed in the chamber. The opening at the distal end of the suction tube is circular, rounded or non-circular in shape, and its edge is curved and / or rounded radius (smooth and atraumatic edge Is).

  A distal portion of the aspiration tube containing the liquefaction and / or destruction chamber can be removably coupled to the main body of the aspiration tube, thereby providing a liquefaction and / or destruction chamber comprising different geometries and / or opening sizes; Can be exchanged and / or replaced. The distance between the distal end of the ultrasound probe and the distal end of the aspiration tube can be adjusted by the user by rotating, sliding, or otherwise adjusting or manipulating the length of the aspiration tube. Such a distance between the distal most point of the tip of the suction tube and the distal most point of the tip of the solid ultrasound probe is preferably variable from 0 to 1.5 cm.

  The user-selected suction tube (adjustable) length can be ensured using a threaded ring or other locking and / or locking mechanism. The total length of the suction tube can be changed within a range of 1 mm to 50 cm depending on application examples and user's preference. The total length of a solid ultrasound probe can also vary from 1 mm to 50 cm.

  The diameter of the hole located at the distal end of the suction tube can vary from 1 mm to 8 mm at its widest point. The outer diameter of the suction tube can be changed in the range of 2 mm to 10 mm. The outer diameter of the solid ultrasonic probe can be changed in the range of 1 mm to 8 mm at its tip (the most distal point with respect to the ultrasonic handpiece).

  The ultrasonic energy is applied to the ultrasonic probe by an ultrasonic handpiece to which the ultrasonic probe is removably coupled. In an alternative embodiment, ultrasonic energy can be applied to the suction tube surrounding the solid ultrasonic probe. In another alternative embodiment, other energy sources (eg, laser, radio frequency, microwave, etc.) can be added to the probe and / or sleeve. When ultrasonic energy is applied to the suction tube, it can be done simultaneously or separately from the ultrasonic energy applied to the solid ultrasonic probe.

  The ultrasonic handpiece converts electrical energy supplied by the generator into mechanical energy (ultrasonic vibration) via a piezoelectric transducer assembly located within the ultrasonic handpiece. The frequency and amplitude ranges of the ultrasonic probe and / or suction tube are typically in the range of 10-35 kHz and 0-300 microns. In alternative embodiments, the range is up to 50 kHz and up to 500 microns.

  The liquefied and / or disrupted adipose tissue is aspirated through the aspiration tube suction path into the liquefaction and / or disruption chamber and then immediately removed through the aspiration connector on the container of the ultrasonic handpiece. The external collector and / or container then receives the liquefied and / or destroyed adipose tissue. Immediate removal of liquefied and / or disrupted adipose tissue from the liquefaction and / or disruption chamber prevents a large number of ultrasonic energy from being continuously applied to the same adipose tissue.

  Accordingly, one or more ultrasound-assisted liposuction devices that improve the safety and efficiency of liposuction procedures compared to conventional suction-assisted liposuction or conventional forms of ultrasound-assisted liposuction Disposable suction tubes for use in the present invention are disclosed herein. This reduces the ultrasonic energy into the suction tube in a manner and amount that achieves the desired liquefaction while limiting the ultrasonic energy so as to prevent irritation and necrosis due to excessive exposure of the ultrasonic energy to the surrounding tissue. This is accomplished at least in part by limiting the probe.

  Non-clinical applications and / or other clinical practices such as ophthalmology, neurology, hepatology, gynecology, urology, otolaryngology, and general external medicine, to name a few It can also be adapted for use in applications.

The present invention and method have the following many advantages over conventional suction assisted liposuction and conventional forms of ultrasound assisted liposuction.
Increased patient safety (minimized risk of skin irritation and skin necrosis).
Patient safety is ensured even while ultrasonic energy is applied for a long time or statically.
Efficiency, including the ability to remove / aspirate larger amounts of adipose tissue (3 to 10 liters) in a single session, is higher compared to existing liposuction techniques.
High tissue specificity for subcutaneous fat.
Less vascular trauma and / or bleeding / blood loss.
Little or no damage to fat surrounding structures, including blood vessels, nerves, and connective tissue.
The ability to safely treat the surface tissue layer (closer to the skin surface) is higher, thereby improving skin atrophy / contraction / tightening.
The ability to treat more anatomical regions of the patient's body safely and effectively improves sculpturality and desired aesthetic results.
The majority of free radicals that can be generated are evacuated simultaneously.
Less surgeon fatigue.
Noise and vibration are minimized.
Compared to conventional suction-assisted liposuction (“SAL”) and conventional forms of ultrasound-assisted liposuction, the total operating time is reduced.
The surgeon's learning curve is short.

  The foregoing description is intended to be illustrative only and is not intended to limit the invention. Many further alternative embodiments according to the present invention will be apparent to those skilled in the art. Accordingly, while certain preferred embodiments of the invention have been disclosed herein, in form and detail, without departing from the spirit and scope of the invention as fully described in the appended claims. It will be apparent to those skilled in the art that various modifications can be made to the present invention.

1 is a side view of an embodiment of an ultrasonic assisted liposuction device according to the present invention. FIG. FIG. 2 is a development view of the embodiment of the ultrasonically assisted liposuction device of FIG. 1. It is a partial sectional side view of embodiment of the ultrasound assisted liposuction instrument of FIG. 4 is an exemplary variation of the size of the opening at the end of the evacuation tube. 4 is an exemplary variation of the size of the opening at the end of the evacuation tube. 4 is an exemplary variation of the size of the opening at the end of the evacuation tube. 4 is an exemplary variation of the size of the opening at the end of the evacuation tube. One possible variation on the shape of the opening at the end of the evacuation tube. It is a figure which shows many opening of the edge part of a vacuum exhaust pipe. It is a figure which shows many opening of the edge part of a vacuum exhaust pipe. FIG. 6 shows a number of openings at the end of the vacuum exhaust tube, including openings in the sidewalls of the distal end of the vacuum exhaust tube in fluid communication with the liquefaction and / or destruction chamber. FIG. 6 is a partial cross-sectional view showing the adjustability of an instrument that adjusts the size of the liquefaction and / or destruction chamber.

Claims (20)

In an adapter for use with an ultrasonic vibrator comprising an ultrasonic probe having a proximal end and a distal end coupled to the ultrasonic vibrator,
A handpiece assembly to which an ultrasonic vibrator is attached and disposed thereto, the first fluid chamber adjacent to the proximal end of the ultrasonic probe between the handpiece assembly and the ultrasonic vibrator. A seal for sealing with respect to the ultrasonic vibrator and the probe for partitioning; a suction conduit coupled in fluid communication with the first chamber and adapted to be coupled to the suction unit; and the first chamber A handpiece assembly having a vacuum opening in fluid communication with the first chamber to adjustably vent
A fluid passage coupled to the handpiece assembly and extending over the ultrasound probe, including the distal end of the ultrasound probe, and defining a fluid passage between the evacuation tube and the probe and in fluid communication with the first chamber With a vacuum exhaust pipe,
The space between the distal end of the probe and the distal end of the evacuation tube provides a second chamber that liquefies and / or destroys adipose tissue, and the evacuation tube is in fluid communication with the second chamber at its distal end. An adapter having at least one opening.   The adapter of claim 1, wherein the distal end of the evacuation tube is rounded with an opening in its center. The adapter of claim 2 , wherein the coupling of the evacuation tube to the handpiece assembly is adjustable to adjust the distance between the distal end of the probe and the distal end of the evacuation tube. An evacuation tube is screwed into the handpiece assembly, and the distance between the distal end of the probe and the distal end of the evacuation tube is adjusted by rotating the evacuation tube relative to the handpiece assembly. The adapter according to claim 3 , which can be used. The adapter according to claim 3 , wherein the opening at the distal end of the vacuum exhaust pipe is round. The adapter according to claim 3 , wherein the opening at the distal end of the vacuum exhaust pipe is rectangular. The adapter according to claim 3 , wherein the vacuum exhaust pipe is a polytetrafluoroethylene vacuum exhaust pipe. The adapter of claim 7 , wherein the handpiece assembly is polytetrafluoroethylene.   The adapter of claim 1, wherein the handpiece assembly is a two-part assembly.   The adapter of claim 1, wherein the evacuation tube has a plurality of openings in fluid communication with the second chamber at a distal end thereof. In an ultrasound assisted liposuction device,
An ultrasonic vibrator comprising an ultrasonic probe having a proximal end and a distal end coupled to the ultrasonic vibrator;
A handpiece assembly to which an ultrasonic vibrator is attached and disposed thereto, the first fluid chamber adjacent to the proximal end of the ultrasonic probe between the handpiece assembly and the ultrasonic vibrator. A seal that seals with respect to the ultrasonic vibrator and the probe for partitioning, a suction passage coupled in fluid communication with the first chamber, coupled to the suction unit, and further adjustably vents the first chamber. A handpiece assembly having a vacuum opening in fluid communication with the first chamber;
Coupled to the handpiece assembly and extending over the ultrasound probe, including the distal end of the ultrasound probe, and forming a fluid passage between the evacuation tube and the probe and in fluid communication with the first chamber With a vacuum exhaust pipe,
The space between the distal end of the probe and the distal end of the evacuation tube provides a second chamber that liquefies and / or destroys adipose tissue, and the evacuation tube is in fluid communication with the second chamber at its distal end. A device having at least one opening. The adapter of claim 11 , wherein the distal end of the evacuation tube is rounded with an opening in the center thereof. 13. The adapter of claim 12 , wherein the coupling of the evacuation tube to the handpiece assembly is adjustable to adjust the distance between the distal end of the probe and the distal end of the evacuation tube. An evacuation tube is screwed into the handpiece assembly, and the distance between the distal end of the probe and the distal end of the evacuation tube is adjusted by rotating the evacuation tube relative to the handpiece assembly The adapter of claim 13 , which can be used. The adapter of claim 13 , wherein the opening at the distal end of the evacuation tube is round. The adapter according to claim 15 , wherein the opening at the distal end of the vacuum exhaust pipe is rectangular. The adapter according to claim 15 , wherein the vacuum exhaust pipe is a polytetrafluoroethylene vacuum exhaust pipe. The adapter of claim 17 , wherein the handpiece assembly is polytetrafluoroethylene. The adapter of claim 11 , wherein the handpiece assembly is a two-part assembly. The adapter of claim 11 , wherein the evacuation tube has a plurality of openings at a distal end thereof and is in fluid communication with the second chamber.

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